摘要
近年来,我国新药研发与药物临床试验发展迅速,药物临床试验获得日渐上升的大众关注度以及进一步推动与发展。与此同时,由药物临床试验不良事件产生的民事法律纠纷亦呈多发趋势。因此,通过对该类纠纷中申办者与研究机构的民事法律责任进行分析,对其涉讼风险进行识别与防控,并对已经发生的民事纠纷的解决路径进行探析具有一定的现实与实践意义。通过对药物临床试验纠纷中主要主体之间法律关系的分析,并结合相关司法案例,探讨申办者与研究机构承担民事责任的情形与风险。从建立风险管控机制、加强受试者知情同意权保护、重视研究团队资质审查与专业素质、发挥法院司法建议和检察院监督作用等方面对药物临床试验中法律责任风险进行规避,同时采取自行审查完善受试者赔偿、补偿机制以及强化监督检查等措施应对已经发生的纠纷。
In recent years,China s new drug R&D and drug clinical trials have developed rapidly.The clinical trials of the drugs have received increasing public attention and further promotion and development.At the same time,civil legal disputes arising from adverse events in drug clinical trials are also frequently met.Therefore,it is of practical significance to analyze the civil legal liability of the sponsor and the research institution in such disputes,to identify and prevent the litigation risks,and to explore the resolution path of the civil disputes that have occurred.Through the analysis of the legal relationship between the main subjects in the drug clinical trial disputes,combining relevant judicial cases,the situation and risk of the sponsor and the research institution bearing civil liability are discussed in this article.From the aspects of establishing a risk management and control mechanism,strengthening the protection of subjects right to informed consent,attaching importance to the qualification review and professional quality of the research team,and giving full play to the role of judicial advice of the court and the supervision of the procuratorate,the legal liability risk in drug clinical trials should be avoided.The measures should be taken to deal with the disputes that have occurred,such as self-review and improvement of the compensation,compensation mechanism of subjects,and strengthening supervision and inspection.
作者
赵天娇
邓勇
ZHAO Tian-jiao;DENG Yong(School of Humanities,Beijing University of Chinese Medicine,Beijing 102488,China)
出处
《中国新药杂志》
北大核心
2025年第5期498-504,共7页
Chinese Journal of New Drugs
